Cleared Traditional

K112852 - BABI PLUS NEONATAL RESUSCITATION BAG

K112852 is an FDA 510(k) clearance for BABI PLUS NEONATAL RESUSCITATION BAG, manufactured by A Plus Medical. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K112852 · A Plus Medical · Anesthesiology device
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Jan 2012
Decision
87d
Days
Class 2
Risk

K112852 is an FDA 510(k) clearance for the BABI PLUS NEONATAL RESUSCITATION BAG. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by A Plus Medical (Carlsbad, US). The FDA issued a Cleared decision on January 13, 2012 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5915 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all A Plus Medical devices

FDA 510(k) Submission Details - K112852

510(k) Number K112852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2011
Decision Date January 13, 2012
Days to Decision 87 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 140d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTM Device Classification - Class 2, Special Controls

Product Code BTM Ventilator, Emergency, Manual (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5915
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BTM Ventilator, Emergency, Manual (resuscitator)

All 102
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K112852.
Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20
K181583 · Flexicare Medical Limited. · Dec 2018
Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer
K170663 · Foremount Enterprise Co., Ltd. · May 2018
Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator
K152931 · Ambu A/S · Aug 2016
AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC
K102824 · Ambu A/S · Jan 2011
RESUSCITATION TIMER, MODEL L770-CPR
K073171 · Allied Healthcare Products, Inc. · Jan 2008
GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM
K070247 · Ohmeda Medical · Apr 2007